The Relationship Between Anxiety Levels of Families and Children Undergoing Magnetic Resonance Imaging Under Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Children's Preoperative Anxiety Levels
研究概览
简要总结
This prospective randomized controlled study evaluates the impact of age-appropriate therapeutic play and structured parental briefing on perioperative anxiety during pediatric MRI under sedation. Children aged 2-11 were assigned to either a multi-modal intervention group or a standard care control group. The primary objective was to measure child anxiety using the Modified Yale Preoperative Anxiety Scale (m-YALE) after the intervention. Secondary objectives included assessing parental anxiety via VAS/APAIS and measuring overall parental satisfaction in the recovery room. The study aims to demonstrate that a brief psychological intervention can effectively reduce stress for both children and their parents, even during prolonged hospital waiting times.
详细描述
The intervention group receives a multi-modal psychological preparation protocol conducted by trained medical students prior to the MRI procedure. The intervention consists of two main components:
Age-Appropriate Therapeutic Play: Children aged 2-7 (Pre-operational stage) receive symbolic medical play using toy kits and masks. Children aged 7-11 (Concrete operational stage) engage in interactive discussions and role-playing for 5-8 minutes.
Structured Parental Briefing: Parents receive a standardized oral briefing covering the MRI working principles, duration of the scan, the role of the anesthesia team, and the recovery process. This is followed by a Q&A session to address specific concerns.
The control group receives the routine preoperative preparation protocol of the Afyonkarahisar Health Sciences University MRI Center. This standard care includes a pre-anesthetic clinical assessment by the anesthesiology team, verification of fasting status (nil per os), and standard institutional monitoring procedures. Unlike the intervention group, participants in the control group do not receive age-appropriate therapeutic play or a structured, standardized parental briefing session prior to sedation. Interaction with medical staff remains limited to routine clinical and administrative procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age Range
- •Procedure Type
- •Caregiver Presence
- •Physical Status
排除标准
- •Cognitive dysfunction
- •Emergency status
- •Psychiatric disorders
- •Medical contraindications
- •Communication barriers
结局指标
主要结局
Children's Preoperative Anxiety Levels
时间窗: Preoperatively, in the waiting room, after the intervention but before the induction of sedation.
Assessed using the Modified Yale Preoperative Anxiety Scale. The total score ranges from a minimum value of 23.33 to a maximum value of 100. Higher scores indicate a worse outcome (greater severity of preoperative anxiety in the child).
次要结局
- Parental Preoperative Anxiety and Information Requirement(Preoperatively, in the waiting room, after the intervention but before the induction of sedation.)
- Parental Preoperative and Postoperative Anxiety Levels(Measured at two distinct time points: preoperatively in the waiting room (post-intervention but before the induction of sedation) and postoperatively in the recovery room.)
研究者
Kamil Taşkapılı
Assistant Professor Doctor
Afyonkarahisar Health Sciences University